A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

December 11, 2009 updated by: Watson Pharmaceuticals

A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia

A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. the following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the Internation Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Study Type

Interventional

Enrollment (Actual)

462

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • California
      • Carmichael, California, United States
      • Fresno, California, United States
      • Laguna Woods, California, United States
      • San Bernardino, California, United States
      • Tarzana, California, United States
      • Torrance, California, United States
    • Florida
      • New Port Richey, Florida, United States
      • Ocala, Florida, United States
      • Orlando, Florida, United States
      • Plantation, Florida, United States
      • Tampa, Florida, United States
      • West Palm Beach, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
      • Melrose Park, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
      • Fort Wayne, Indiana, United States
    • Kansas
      • Overland Park, Kansas, United States
    • Maryland
      • Greenbelt, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • Missouri
      • Kansas City, Missouri, United States
    • New Jersey
      • Lawrenceville, New Jersey, United States
      • Voorhees, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Albany, New York, United States
      • Garden City, New York, United States
      • Kingston, New York, United States
      • Poughkeepsie, New York, United States
    • North Carolina
      • Concord, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • South Carolina
      • Mt. Pleasant, South Carolina, United States
      • Myrtle Beach, South Carolina, United States
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States
    • Washington
      • Seattle, Washington, United States
      • Tacoma, Washington, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH.

Exclusion Criteria:

  • Medical conditions that would confound the efficacy evaluation.
  • Medical conditions in which it would be unsafe to use an alpha-blocker.
  • The use of concomitant drugs that would confound the efficacy evaluation.
  • The use of concomitant drugs that would be unsafe with this alpha-blocker.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Silodosin
Silodosin 8 mg/Day with food
Drug: Silodosin
8 mg daily for 12 weeks
Other Names:
  • Rapaflo
Placebo Comparator: Placebo
Matching placebo capsule once daily with food
Other: Placebo
One capsule daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks
Time Frame: Baseline and 12 weeks
International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Watson Pharmaceuticals

Investigators

  • Study Director: Lawrence Hill, PharmD, RPh, Watson Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 15, 2009

Last Update Submitted That Met QC Criteria

December 11, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SI04010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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